(69 days)
Galvanic Skin Response Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Akuport M-2" device, a galvanic skin response measurement device. This type of document primarily confirms that a new device is "substantially equivalent" to an existing legally marketed device and can therefore be marketed.
It explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
The FDA 510(k) clearance process, especially for galvanic skin response devices, does not typically require or include detailed information about acceptance criteria, performance studies (like those described in your prompt), or analyses of clinical accuracy in the same way a PMA (Premarket Approval) would for high-risk devices or a de novo classification for novel devices.
The document grants clearance based on substantial equivalence, implying the device performs similarly to predicate devices already on the market, not necessarily on specific performance metrics or clinical study outcomes such as accuracy, sensitivity, or specificity against a ground truth.
Therefore, I cannot provide the requested information from the given text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study information or effect sizes.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The "Indications For Use" section states: "Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This further emphasizes the lack of clinical performance claims or studies within this clearance document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2002
Mr. Stephen Emond President Vibrant Health D/O 1182508 Ontario Ltd 150 Des Grands Coteaux Beloeil, Quebec Canada, J3G 2C9
Re: K020568
Trade/Device Name: Akuport M-2 Regulation Number: 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: II Product Code: GZO Dated: February 11, 2002 Received: February 20, 2002
Dear Mr. Emond:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Stephen Emond
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
uriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) #: K020568 Product: Akuport M-2
Indications For Use:
Galvanic Skin Response
Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin.
There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K0206568
§ 882.1540 Galvanic skin response measurement device.
(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.